Healthy
Conditions
Brief summary
The purpose of this study is to assess how fast galcanezumab gets into the blood stream and how long it takes the body to remove it. Information about side effects will be collected. The study is open to healthy Chinese participants. It will last up to about 24 weeks.
Interventions
DRUGGalcanezumab
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants who are native Chinese (all 4 biological grandparents and both biological parents to be of Chinese origin) * Participants who are overtly healthy males or females, as determined by medical history and physical examination
Exclusion criteria
* Participants who are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study * Participants who have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed * Participants who have received treatment with any CGRP (calcitonin gene related peptide) antibody (including galcanezumab), or antibody against CGRP receptor (including erenumab), or have received biologic agents (such as monoclonal antibodies) within 4 months or 5 half-lives (whichever is longer) prior to dosing * Participants who have a history of multiple or severe allergies or has had an anaphylactic reaction to prescription or non-prescription drugs or food * women who are lactating * Participants who show evidence of positive human immunodeficiency virus antibodies, or positive hepatitis C antibody, or positive hepatitis B surface antigen, or active tuberculosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab | 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose | Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab. |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab | 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC\[0-∞\]) of Galcanezumab. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received a single Subcutaneous (SC) dose of Placebo. | 6 |
| 120 mg Galcanezumab SC Participants received a single SC dose of 120 milligram (mg) Galcanezumab. | 12 |
| 240 mg Galcanezumab SC Participants received a single SC dose of 240 mg Galcanezumab. | 12 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | 240 mg Galcanezumab SC | Total | Placebo | 120 mg Galcanezumab SC |
|---|---|---|---|---|
| Age, Continuous | 28.80 years STANDARD_DEVIATION 4.09 | 27.60 years STANDARD_DEVIATION 4.91 | 26.70 years STANDARD_DEVIATION 4.18 | 26.80 years STANDARD_DEVIATION 6.03 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 30 Participants | 6 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 30 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 12 Participants | 30 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Female | 1 Participants | 7 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 11 Participants | 23 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 5 / 6 | 12 / 12 | 12 / 12 |
| serious Total, serious adverse events | 0 / 6 | 2 / 12 | 1 / 12 |
Outcome results
Primary
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC\[0-∞\]) of Galcanezumab.
Time frame: 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose
Population: All randomized participants who received at least one dose of Galcanezumab.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 120 mg Galcanezumab SC | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab | 558 micrograms*day per milliliter(μg*day/mL) | Geometric Coefficient of Variation 36 |
| 240 mg Galcanezumab SC | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab | 1190 micrograms*day per milliliter(μg*day/mL) | Geometric Coefficient of Variation 27 |
Primary
Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab
Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.
Time frame: 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose
Population: All randomized participants who received at least one dose of Galcanezumab.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 120 mg Galcanezumab SC | Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab | 12.6 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 23 |
| 240 mg Galcanezumab SC | Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab | 27.2 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 23 |