None - Study is to Determine Safety in Healthy Participants
Conditions
Brief summary
A phase I double-blind, placebo-controlled, randomized, single and multiple ascending dose finding study to evaluate the safety and pharmacokinetic profile of LSALT peptide in healthy participants
Interventions
DRUGLSALT peptide
novel 16 amino acid peptide
OTHER0.9% Saline
saline
Sponsors
Arch Biopartners Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Pharmacist not blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* No prior history of major organ or systemic disease including diabetes, hypertension, kidney, heart or liver disease. Participants with childhood asthma are acceptable. * Normal hematology, clinical chemistry and urinalysis parameters at screening, unless not deemed clinically significant by the investigator. * Body Mass Index (BMI) between 18 kg/m2 and 32 kg/m2 (inclusive) * Taking no prescription medications 2 weeks prior to admission or over-the-counter medications 7 days prior to admission. Occasional use of paracetamol or ibuprofen (up to 1000 mg and 400 mg/day respectively) are acceptable. Routine vitamins and supplements are permissible at the discretion of the investigator. * Able to allow intravenous medication to be administered. * Males (along with their female partners) and females of childbearing potential (defined as a female who is not menopausal or surgically sterilized) must be willing to use an acceptable method of birth control during heterosexual activities including a condom and a second highly effective method (i.e., hormonal contraceptive, intra-uterine device) or abstinence for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Males should continue with the aforementioned contraception for 90 days after the last dose and females should continue with the aforementioned contraception for 60 days after last dose. * Able to understand and willing to sign an ethics committee-approved written informed consent document * Non-smokers. Social and light smokers of up to 10 cigarettes per day who can abstain from smoking during the confinement period and have no evidence of underlying lung disease (bronchitis, COPD or reactive airways disease). * Willing to remain abstinent from alcohol 24 hours prior to admission and until after the confinement period in the unit.
Exclusion criteria
* A history of cardiovascular disease, diabetes or hypertension (\>150/90 after 5 minutes sitting), significant neurological, pulmonary (including asthma), hepatic, rheumatic, autoimmune, haematological, metabolic or renal disorder. * Prescription medications are prohibited. No prescription medications 2 weeks prior to admission or over-the-counter medications 7 days prior to admission. Occasional use of paracetamol or ibuprofen (up to 1000 mg and 400 mg/day respectively) are acceptable. Routine vitamins and supplements are permissible at the discretion of the investigator. * Any moderate or severe allergies, including anaphylaxis, to food, drugs or environmental allergens. Mild allergies such as hayfever may be included. * Females who are pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study initiation and at baseline. * Consumption of caffeine 48 hours prior to start of study treatment and whilst confined to the unit. * History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study * Clinically significant abnormal laboratory value at screening as determined by the Investigator. * Participant is sero-positive to HIV-1 or HIV-2, HCV or HBV. * History or presence of alcoholism within two years prior to the first study drug administration or drugs of abuse unless it can be explained to the satisfaction of the investigator that it is due to a standard dose of a prescribed medication and that an adequate wash-out will occur prior to admission. * No findings on clinical examination that, in the opinion of the investigator, could compromise the safety of the participant or the results of the study. * Blood donation or significant blood loss within 60 days prior to the first study drug administration. * Administration of investigational product in another trial within 30 days prior to the first study drug administration or five half-lives, whichever is longer. * Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant. * Active malignancy or history of malignancy in the past 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluation | Within 21 days | To determine the safety and tolerability of 3 single and multiple ascending doses of LSALT peptide (1.0mg, 2.5mg, 5.0mg) in healthy participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Evaluation | Within 21 days | To evaluate the PK and pharmacodynamics (PD) of LSALT peptide in healthy participants. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LSALT Peptide - 0.01mg LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.1mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide | 1 |
| LSALT Peptide - 0.1mg LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.3mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide | 1 |
| LSALT Peptide - 0.3mg LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.5mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide | 1 |
| LSALT Peptide - 0.5mg LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 1.0mg dose in next cohort if no adverse effects are seen after 10-14 days.
LSALT peptide: novel 16 amino acid peptide | 1 |
| LSALT Peptide - 1.0mg LSALT peptide (1mg/mL in 0.9% saline) single dose - 1.0mg intravenously over 2h.
Escalation to next dose (2.5mg) in next cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide | 6 |
| LSALT Peptide - 2.5mg LSALT peptide (1mg/mL in 0.9% saline) single dose - 2.5mg intravenously over 2h.
Escalation to next dose (5.0mg) in next cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide | 6 |
| LSALT Peptide - 5.0mg LSALT peptide (1mg/mL in 0.9% saline) single dose - 5.0mg intravenously over 2h.
Escalation to multiple ascending dose cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide | 6 |
| Placebo - Single Dose 0.9% saline as placebo for single dose cohorts (1.0mg, 2.5mg, 5.0mg) | 6 |
| LSALT Peptide - 1.0mg, Multiple Ascending Dose LSALT peptide (1mg/mL in 0.9% saline) single dose (1.0mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide | 6 |
| LSALT Peptide - 2.5mg, Multiple Ascending Dose LSALT peptide (1mg/mL in 0.9% saline) single dose (2.5mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide | 6 |
| LSALT Peptide - 5.0mg, Multiple Ascending Dose LSALT peptide (1mg/mL in 0.9% saline) single dose (5.0mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide | 6 |
| Placebo - Multiple Ascending Dose 0.9% saline as placebo for multiple ascending dose cohorts | 6 |
| Total | 52 |
Baseline characteristics
| Characteristic | LSALT Peptide - 0.1mg | LSALT Peptide - 0.3mg | LSALT Peptide - 0.5mg | LSALT Peptide - 1.0mg | LSALT Peptide - 2.5mg | LSALT Peptide - 5.0mg | LSALT Peptide - 0.01mg | Placebo - Single Dose | LSALT Peptide - 1.0mg, Multiple Ascending Dose | LSALT Peptide - 2.5mg, Multiple Ascending Dose | LSALT Peptide - 5.0mg, Multiple Ascending Dose | Placebo - Multiple Ascending Dose | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 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 |
| 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 |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 1 Participants | 6 Participants | 6 Participants | 6 Participants | 1 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 52 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 |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 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 |
| 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 1 Participants | 4 Participants | 3 Participants | 4 Participants | 0 Participants | 5 Participants | 3 Participants | 3 Participants | 4 Participants | 4 Participants | 33 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 3 Participants | 2 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 3 Participants | 4 Participants | 0 Participants | 3 Participants | 5 Participants | 4 Participants | 3 Participants | 4 Participants | 31 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 3 / 6 | 1 / 6 | 6 / 6 | 2 / 6 | 5 / 6 | 4 / 6 | 2 / 6 | 5 / 6 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Safety Evaluation
To determine the safety and tolerability of 3 single and multiple ascending doses of LSALT peptide (1.0mg, 2.5mg, 5.0mg) in healthy participants.
Time frame: Within 21 days
Population: The Safety Population was comprised of all randomised subjects who received any amount of study drug in the single ascending dose and multiple ascending dose cohorts and were based on the actual treatment received, if this differs from that to which the subject was randomised. The Safety Population was used for the summaries of all safety tolerability.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LSALT Peptide - 1.0mg | Safety Evaluation | At least One Serious Study Drug-related TEAE | 0 participants |
| LSALT Peptide - 1.0mg | Safety Evaluation | At least One TEAE | 3 participants |
| LSALT Peptide - 1.0mg | Safety Evaluation | Death | 0 participants |
| LSALT Peptide - 1.0mg | Safety Evaluation | At least One Severe or Life-threatening TEAE | 0 participants |
| LSALT Peptide - 1.0mg | Safety Evaluation | Discontinuation due to TEAE | 0 participants |
| LSALT Peptide - 1.0mg | Safety Evaluation | At least One Serious TEAE | 0 participants |
| LSALT Peptide - 1.0mg | Safety Evaluation | At least One Study Drug-related TEAE | 0 participants |
| LSALT Peptide - 2.5mg | Safety Evaluation | At least One Severe or Life-threatening TEAE | 0 participants |
| LSALT Peptide - 2.5mg | Safety Evaluation | Discontinuation due to TEAE | 0 participants |
| LSALT Peptide - 2.5mg | Safety Evaluation | At least One Serious Study Drug-related TEAE | 0 participants |
| LSALT Peptide - 2.5mg | Safety Evaluation | Death | 0 participants |
| LSALT Peptide - 2.5mg | Safety Evaluation | At least One TEAE | 1 participants |
| LSALT Peptide - 2.5mg | Safety Evaluation | At least One Serious TEAE | 0 participants |
| LSALT Peptide - 2.5mg | Safety Evaluation | At least One Study Drug-related TEAE | 0 participants |
| LSALT Peptide - 5.0mg | Safety Evaluation | Death | 0 participants |
| LSALT Peptide - 5.0mg | Safety Evaluation | Discontinuation due to TEAE | 0 participants |
| LSALT Peptide - 5.0mg | Safety Evaluation | At least One Serious Study Drug-related TEAE | 0 participants |
| LSALT Peptide - 5.0mg | Safety Evaluation | At least One Study Drug-related TEAE | 2 participants |
| LSALT Peptide - 5.0mg | Safety Evaluation | At least One Serious TEAE | 0 participants |
| LSALT Peptide - 5.0mg | Safety Evaluation | At least One Severe or Life-threatening TEAE | 0 participants |
| LSALT Peptide - 5.0mg | Safety Evaluation | At least One TEAE | 6 participants |
| Placebo - Single Dose | Safety Evaluation | At least One TEAE | 2 participants |
| Placebo - Single Dose | Safety Evaluation | Death | 0 participants |
| Placebo - Single Dose | Safety Evaluation | At least One Severe or Life-threatening TEAE | 0 participants |
| Placebo - Single Dose | Safety Evaluation | At least One Study Drug-related TEAE | 1 participants |
| Placebo - Single Dose | Safety Evaluation | At least One Serious TEAE | 0 participants |
| Placebo - Single Dose | Safety Evaluation | At least One Serious Study Drug-related TEAE | 0 participants |
| Placebo - Single Dose | Safety Evaluation | Discontinuation due to TEAE | 0 participants |
| LSALT Peptide - 1.0mg, Multiple Ascending Dose | Safety Evaluation | Discontinuation due to TEAE | 0 participants |
| LSALT Peptide - 1.0mg, Multiple Ascending Dose | Safety Evaluation | At least One TEAE | 5 participants |
| LSALT Peptide - 1.0mg, Multiple Ascending Dose | Safety Evaluation | At least One Serious Study Drug-related TEAE | 0 participants |
| LSALT Peptide - 1.0mg, Multiple Ascending Dose | Safety Evaluation | Death | 0 participants |
| LSALT Peptide - 1.0mg, Multiple Ascending Dose | Safety Evaluation | At least One Study Drug-related TEAE | 3 participants |
| LSALT Peptide - 1.0mg, Multiple Ascending Dose | Safety Evaluation | At least One Serious TEAE | 0 participants |
| LSALT Peptide - 1.0mg, Multiple Ascending Dose | Safety Evaluation | At least One Severe or Life-threatening TEAE | 0 participants |
| LSALT Peptide - 2.5mg, Multiple Ascending Dose | Safety Evaluation | At least One Serious Study Drug-related TEAE | 0 participants |
| LSALT Peptide - 2.5mg, Multiple Ascending Dose | Safety Evaluation | At least One Severe or Life-threatening TEAE | 0 participants |
| LSALT Peptide - 2.5mg, Multiple Ascending Dose | Safety Evaluation | At least One TEAE | 4 participants |
| LSALT Peptide - 2.5mg, Multiple Ascending Dose | Safety Evaluation | Death | 0 participants |
| LSALT Peptide - 2.5mg, Multiple Ascending Dose | Safety Evaluation | At least One Serious TEAE | 0 participants |
| LSALT Peptide - 2.5mg, Multiple Ascending Dose | Safety Evaluation | Discontinuation due to TEAE | 0 participants |
| LSALT Peptide - 2.5mg, Multiple Ascending Dose | Safety Evaluation | At least One Study Drug-related TEAE | 1 participants |
| LSALT Peptide - 5.0mg, Multiple Ascending Dose | Safety Evaluation | At least One Severe or Life-threatening TEAE | 0 participants |
| LSALT Peptide - 5.0mg, Multiple Ascending Dose | Safety Evaluation | Discontinuation due to TEAE | 0 participants |
| LSALT Peptide - 5.0mg, Multiple Ascending Dose | Safety Evaluation | At least One Study Drug-related TEAE | 1 participants |
| LSALT Peptide - 5.0mg, Multiple Ascending Dose | Safety Evaluation | At least One Serious Study Drug-related TEAE | 0 participants |
| LSALT Peptide - 5.0mg, Multiple Ascending Dose | Safety Evaluation | At least One TEAE | 2 participants |
| LSALT Peptide - 5.0mg, Multiple Ascending Dose | Safety Evaluation | Death | 0 participants |
| LSALT Peptide - 5.0mg, Multiple Ascending Dose | Safety Evaluation | At least One Serious TEAE | 0 participants |
| Placebo - Multiple Ascending Dose | Safety Evaluation | At least One Serious TEAE | 0 participants |
| Placebo - Multiple Ascending Dose | Safety Evaluation | At least One Study Drug-related TEAE | 1 participants |
| Placebo - Multiple Ascending Dose | Safety Evaluation | Discontinuation due to TEAE | 0 participants |
| Placebo - Multiple Ascending Dose | Safety Evaluation | At least One TEAE | 5 participants |
| Placebo - Multiple Ascending Dose | Safety Evaluation | Death | 0 participants |
| Placebo - Multiple Ascending Dose | Safety Evaluation | At least One Serious Study Drug-related TEAE | 0 participants |
| Placebo - Multiple Ascending Dose | Safety Evaluation | At least One Severe or Life-threatening TEAE | 0 participants |
Secondary
Pharmacokinetic Evaluation
To evaluate the PK and pharmacodynamics (PD) of LSALT peptide in healthy participants.
Time frame: Within 21 days
Population: The PK Concentration Population was comprised of all subjects who received any amount of LSALT, who had at least 1 quantifiable PK concentration and was based on the actual treatment received, if this differs from that to which the subject was randomized. Subjects who received only placebo was excluded from the PK Concentration Population. The PK Concentration Population was used for the summaries of all PK concentration data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LSALT Peptide - 0.01mg | Pharmacokinetic Evaluation | T1/2 (h) | 0.41 hours | Standard Deviation 0.147 |
| LSALT Peptide - 0.01mg | Pharmacokinetic Evaluation | Tmax (h) | 1.33 hours | Standard Deviation 0.6 |
| LSALT Peptide - 0.1mg | Pharmacokinetic Evaluation | T1/2 (h) | 0.21 hours | Standard Deviation 0.075 |
| LSALT Peptide - 0.1mg | Pharmacokinetic Evaluation | Tmax (h) | 1.17 hours | Standard Deviation 0.516 |