Cerebrovascular Stroke, Intracranial Arteriosclerosis, Large-Artery Atherosclerosis (Embolus/Thrombosis)
Conditions
Keywords
Secondary Stroke Prevention
Brief summary
Study BT200-01 is a first in human (FIH) study in male and female normal human volunteers (NHVs) that uses an Integrated Protocol Design. This Phase 1 study will comprise 4 sub-parts: Part A, a single ascending dose (SAD) study; Part B, a multiple ascending dose (MAD) study; Part C, a desmopressin challenge study to explore (i) whether desmopressin could be used as an antidote, and/or (ii) whether desmopressin stimulated vonWillebrand Factor (VWF) release is overcome with increasing BT200 doses; and Part D, a relative bioavailability (BA) study. The primary objective of this study is to assess the safety and tolerability profile of BT200 in NHVs.
Interventions
DRUGBT200
BT200 is a PEGylated synthetic RNA oligonucleotide
DRUGDesmopressin
Sterile solution for injection
DRUGPlacebo
Sterile saline for injection
Sponsors
Band Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female volunteers, age ≥ 18 years old at screening 2. If female, must be post-menopausal or status post hysterectomy 3. Able to comprehend and to give informed consent 4. Able to cooperate with the Investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures
Exclusion criteria
1. Clinically significant medical history (including von Willebrand Disease, thrombocytopathy, or any type of bleeding diathesis) or ongoing chronic illness that would jeopardize the safety of the subject or compromise the quality of the data derived from his/her participation in this study 2. Clinically relevant abnormal findings on physical examination or clinically relevant laboratory abnormalities 3. History of infusion hypersensitivity reactions, significant drug allergy, or anaphylactic reactions 4. Substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the Investigator for the subject to be able to comply fully with study procedures 5. Use of medication during 2 weeks before the start of the study, which in the judgment of the Investigator may adversely affect the subject's welfare or the integrity of the study's results 6. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 elimination half-lives (whichever is longer) prior to treatment start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Baseline through 8 weeks after dosing up to 56 days | Any AE or bleeding event related to study treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measured Area Under the Curve (AUC) | Baseline through 8 weeks after dosing up to 56 days | Measured Area Under the Curve at timepoints pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d post dose |
| Maximum Plasma Concentration (Cmax) | Baseline through 8 weeks after dosing up to 56 days | Maximum plasma Concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d |
| Time to Maximum Plasma Concentration (Tmax) | Baseline through 8 weeks after dosing up to 56 days | Time to maximum plasma concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d |
Countries
Austria
Participant flow
Recruitment details
Subjects were recruited from the Medical University of Vienna Phase 1 Unit's database of Normal Human Volunteers and a recruitment vendor was also employed.
Participants by arm
| Arm | Count |
|---|---|
| BT200 0.18mg Subjects will receive a single subcutaneous dose of BT200 0.18mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 6 |
| BT200 0.6mg Subjects will receive a single subcutaneous dose of BT200 0.6mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 6 |
| BT200 1.8mg Subjects will receive a single subcutaneous dose of BT200 1.8mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 6 |
| BT200 6.0mg Subjects will receive a single subcutaneous dose of BT200 6.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 6 |
| BT200 12.0mg Subjects will receive a single subcutaneous dose of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 6 |
| BT200 24.0mg Subjects will receive a single subcutaneous dose of BT200 24.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 6 |
| BT200 24.0mg Rep Subjects will receive a single subcutaneous (SC) dose of BT200 24.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 6 |
| Placebo SAD Subjects will receive a single subcutaneous dose of placebo
Placebo: Sterile saline for injection | 20 |
| BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg Subjects will receive an initial subcutaneous loading doses of BT200 12.0mg followed by 4 weekly (every 7 days) maintenance doses of BT200 12.0mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 6 |
| BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg Subjects will receive an initial subcutaneous loading dose of BT200 24mg followed by 4 weekly (every 7 days) maintenance doses of BT200 24mg
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 6 |
| Placebo MAD Subjects will receive an initial subcutaneous loading dose of Placebo followed by 4 weekly (every 7 days) maintenance doses of placebo
Placebo: Sterile saline for injection | 4 |
| BT200 48.0mg + Desmopressin Challenge Subjects will receive a single subcutaneous dose of BT200 48.0mg followed by IV infusion (over 30 min) of 0.3µg/kg desmopressin administered 24 hours after single dose of BT200
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection | 6 |
| Placebo + Desmopressin Challenge Dose Subjects will receive a single subcutaneous dose of placebo followed by IV infusion (over 30 min of 0.3µg/kg desmopressin administered 24 hours after single dose of placebo
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide
Desmopressin: Sterile solution for injection | 2 |
| Placebo Infusion Subjects will receive a single IV dose of placebo administered over 24 hours
Placebo: Sterile saline for injection | 2 |
| BT200 36.0mg Subjects will receive a single subcutaneous (SC) dose of BT200 36.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 6 |
| BT200 48.0 mg Subjects will receive a single subcutaneous dose (SC) of BT200 48.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 6 |
| BT200 18.0 mg Subjects will receive a single subcutaneous (SC) dose of BT200 18.0mg by gradual SC infusion
BT200: BT200 is a PEGylated synthetic RNA oligonucleotide | 6 |
| BT 200 24mg IV Infusion Subjects will receive a single IV dose of BT200 24mg administered over 24 hours | 6 |
| Total | 112 |
Baseline characteristics
| Characteristic | BT200 0.18mg | BT200 0.6mg | BT200 1.8mg | BT200 6.0mg | BT200 12.0mg | BT200 24.0mg | BT200 24.0mg Rep | Placebo SAD | BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg | BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg | Placebo MAD | BT200 48.0mg + Desmopressin Challenge | Placebo + Desmopressin Challenge Dose | Placebo Infusion | BT200 36.0mg | BT200 48.0 mg | BT200 18.0 mg | BT 200 24mg IV Infusion | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 6 Participants | 19 Participants | 6 Participants | 5 Participants | 4 Participants | 6 Participants | 2 Participants | 2 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 109 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 20 Participants | 6 Participants | 6 Participants | 4 Participants | 6 Participants | 2 Participants | 2 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 6 Participants | 6 Participants | 20 Participants | 6 Participants | 5 Participants | 4 Participants | 6 Participants | 2 Participants | 1 Participants | 6 Participants | 6 Participants | 5 Participants | 5 Participants | 106 Participants |
| Region of Enrollment Austria | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 20 participants | 6 participants | 6 participants | 4 participants | 6 participants | 2 participants | 2 participants | 6 participants | 6 participants | 6 participants | 6 participants | 112 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 11 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 4 Participants | 18 Participants | 5 Participants | 6 Participants | 3 Participants | 5 Participants | 2 Participants | 2 Participants | 6 Participants | 5 Participants | 6 Participants | 6 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 20 | 0 / 6 | 0 / 6 | 0 / 4 | 0 / 6 | 0 / 2 | 0 / 2 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 4 / 6 | 3 / 6 | 4 / 6 | 4 / 6 | 5 / 6 | 6 / 6 | 5 / 6 | 16 / 20 | 6 / 6 | 6 / 6 | 4 / 4 | 5 / 6 | 1 / 2 | 1 / 2 | 4 / 6 | 4 / 6 | 5 / 6 | 4 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 1 / 6 | 1 / 20 | 0 / 6 | 1 / 6 | 0 / 4 | 0 / 6 | 0 / 2 | 0 / 2 | 0 / 6 | 1 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Any AE or bleeding event related to study treatment
Time frame: Baseline through 8 weeks after dosing up to 56 days
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BT200 0.18mg | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 0 Participants |
| BT200 0.6mg | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 1 Participants |
| BT200 1.8mg | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 0 Participants |
| BT200 6.0mg | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 1 Participants |
| BT200 12.0mg | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 1 Participants |
| BT200 24.0mg | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 0 Participants |
| BT200 24.0mg Rep | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 1 Participants |
| Placebo SAD | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 2 Participants |
| BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 4 Participants |
| BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 3 Participants |
| Placebo MAD | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 3 Participants |
| BT200 48.0mg + Desmopressin Challenge | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 3 Participants |
| Placebo + Desmopressin Challenge Dose | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 0 Participants |
| Placebo Infusion | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 0 Participants |
| BT200 36.0mg | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 0 Participants |
| BT200 48.0 mg | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 3 Participants |
| BT200 18.0 mg | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 2 Participants |
| BT200 24mg IV Infusion | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 0 Participants |
Secondary
Maximum Plasma Concentration (Cmax)
Maximum plasma Concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d
Time frame: Baseline through 8 weeks after dosing up to 56 days
Population: Per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BT200 0.18mg | Maximum Plasma Concentration (Cmax) | 0.01025 ug/mL | Standard Deviation 0.0055459 |
| BT200 0.6mg | Maximum Plasma Concentration (Cmax) | 0.04688 ug/mL | Standard Deviation 0.018522 |
| BT200 1.8mg | Maximum Plasma Concentration (Cmax) | 0.09432 ug/mL | Standard Deviation 0.035964 |
| BT200 6.0mg | Maximum Plasma Concentration (Cmax) | 0.5087 ug/mL | Standard Deviation 0.1843 |
| BT200 12.0mg | Maximum Plasma Concentration (Cmax) | 1.258 ug/mL | Standard Deviation 0.3554 |
| BT200 24.0mg | Maximum Plasma Concentration (Cmax) | 2.092 ug/mL | Standard Deviation 0.07627 |
| BT200 24.0mg Rep | Maximum Plasma Concentration (Cmax) | 2.080 ug/mL | Standard Deviation 0.46217 |
| Placebo SAD | Maximum Plasma Concentration (Cmax) | 3.013 ug/mL | Standard Deviation 0.25185 |
| BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg | Maximum Plasma Concentration (Cmax) | 5.823 ug/mL | Standard Deviation 1.3606 |
| BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg | Maximum Plasma Concentration (Cmax) | 6.598 ug/mL | Standard Deviation 2.6719 |
| Placebo MAD | Maximum Plasma Concentration (Cmax) | 3.248 ug/mL | Standard Deviation 11724 |
| BT200 48.0mg + Desmopressin Challenge | Maximum Plasma Concentration (Cmax) | 5.525 ug/mL | Standard Deviation 0.95429 |
| Placebo + Desmopressin Challenge Dose | Maximum Plasma Concentration (Cmax) | 1.742 ug/mL | Standard Deviation 0.49545 |
| Placebo Infusion | Maximum Plasma Concentration (Cmax) | 5.037 ug/mL | Standard Deviation 1.3953 |
Secondary
Measured Area Under the Curve (AUC)
Measured Area Under the Curve at timepoints pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d post dose
Time frame: Baseline through 8 weeks after dosing up to 56 days
Population: Per protocol population-(h\*ug/mL)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BT200 0.18mg | Measured Area Under the Curve (AUC) | 1.159 h*ug/mL | Standard Deviation 0.72594 |
| BT200 0.6mg | Measured Area Under the Curve (AUC) | 5.405 h*ug/mL | Standard Deviation 2.1113 |
| BT200 1.8mg | Measured Area Under the Curve (AUC) | 11.50 h*ug/mL | Standard Deviation 6.5663 |
| BT200 6.0mg | Measured Area Under the Curve (AUC) | 64.39 h*ug/mL | Standard Deviation 22.534 |
| BT200 12.0mg | Measured Area Under the Curve (AUC) | 161.6 h*ug/mL | Standard Deviation 43.427 |
| BT200 24.0mg | Measured Area Under the Curve (AUC) | 259.5 h*ug/mL | Standard Deviation 99.216 |
| BT200 24.0mg Rep | Measured Area Under the Curve (AUC) | 265.3 h*ug/mL | Standard Deviation 59.127 |
| Placebo SAD | Measured Area Under the Curve (AUC) | 409.4 h*ug/mL | Standard Deviation 32.347 |
| BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg | Measured Area Under the Curve (AUC) | 806.8 h*ug/mL | Standard Deviation 187.25 |
| BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg | Measured Area Under the Curve (AUC) | 675.9 h*ug/mL | Standard Deviation 204.8 |
| Placebo MAD | Measured Area Under the Curve (AUC) | 366.2 h*ug/mL | Standard Deviation 78.61 |
| BT200 48.0mg + Desmopressin Challenge | Measured Area Under the Curve (AUC) | 638.8 h*ug/mL | Standard Deviation 90.467 |
| Placebo + Desmopressin Challenge Dose | Measured Area Under the Curve (AUC) | 220.3 h*ug/mL | Standard Deviation 64.58 |
| Placebo Infusion | Measured Area Under the Curve (AUC) | 555.4 h*ug/mL | Standard Deviation 126.99 |
Secondary
Time to Maximum Plasma Concentration (Tmax)
Time to maximum plasma concentration measured at pre-dose, 0.5h, 1h, 4h, 8h,14h, 24h, 48h, 72h, 96h, 168h, 14d, 21d, 28d, 42d, 56d
Time frame: Baseline through 8 weeks after dosing up to 56 days
Population: per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BT200 0.18mg | Time to Maximum Plasma Concentration (Tmax) | 111.867 (h) | Standard Deviation 111.7018 |
| BT200 0.6mg | Time to Maximum Plasma Concentration (Tmax) | 80.433 (h) | Standard Deviation 20.2385 |
| BT200 1.8mg | Time to Maximum Plasma Concentration (Tmax) | 72.364 (h) | Standard Deviation 22.0757 |
| BT200 6.0mg | Time to Maximum Plasma Concentration (Tmax) | 100.239 (h) | Standard Deviation 53.4433 |
| BT200 12.0mg | Time to Maximum Plasma Concentration (Tmax) | 72.761 (h) | Standard Deviation 21.4536 |
| BT200 24.0mg | Time to Maximum Plasma Concentration (Tmax) | 100.247 (h) | Standard Deviation 38.5146 |
| BT200 24.0mg Rep | Time to Maximum Plasma Concentration (Tmax) | 88.517 (h) | Standard Deviation 19.7697 |
| Placebo SAD | Time to Maximum Plasma Concentration (Tmax) | 29.892 (h) | Standard Deviation 25.8845 |
| BT200 Loading Dose 12.0mg, Maintenance Doses of 12.0 mg | Time to Maximum Plasma Concentration (Tmax) | 12.811 (h) | Standard Deviation 17.9877 |
| BT200 Loading Doses 24.0mg, Maintenance Doses of 24.0 mg | Time to Maximum Plasma Concentration (Tmax) | 105.919 (h) | Standard Deviation 18.9321 |
| Placebo MAD | Time to Maximum Plasma Concentration (Tmax) | 139.647 (h) | Standard Deviation 46.6683 |
| BT200 48.0mg + Desmopressin Challenge | Time to Maximum Plasma Concentration (Tmax) | 107.892 (h) | Standard Deviation 113.4475 |
| Placebo + Desmopressin Challenge Dose | Time to Maximum Plasma Concentration (Tmax) | 100.247 (h) | Standard Deviation 38.5146 |
| Placebo Infusion | Time to Maximum Plasma Concentration (Tmax) | 23.864 (h) | Standard Deviation 0.2642 |