Phase 1 SAD and MAD Study of NGM282 in Healthy Adult Participants
A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM282 in Healthy Adult Participants
1 other identifier
interventional
119
1 country
1
Brief Summary
The purpose of this study is to determine the safety and tolerability of NGM282, both single dose and multiple doses, in normal healthy adult participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes-mellitus
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 18, 2013
CompletedFirst Posted
Study publicly available on registry
January 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedDecember 31, 2013
December 1, 2013
6 months
January 18, 2013
December 30, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.
7 days and 14 days
Secondary Outcomes (2)
Pharmacokinetics
7 days and 14 days
Pharmacodynamics
7 days and 14 days
Study Arms (12)
Cohort 1 SAD
EXPERIMENTALNGM282 Dose 1 vs Placebo
Cohort 2 SAD
EXPERIMENTALNGM282 Dose 2 vs Placebo
Cohort 3 SAD
EXPERIMENTALNGM282 Dose 3 vs Placebo
Cohort 4 SAD
EXPERIMENTALNGM282 Dose 4 vs Placebo
Cohort 5 SAD
EXPERIMENTALNGM282 Dose 5 vs Placebo
Cohort 6 SAD
EXPERIMENTALNGM282 Dose 6 vs Placebo
Cohort 7 MAD
EXPERIMENTALNGM282 Dose 1 vs Placebo
Cohort 8 MAD
EXPERIMENTALNGM282 Dose 2 vs Placebo
Cohort 9 MAD
EXPERIMENTALNGM282 Dose 3 vs Placebo
Cohort 10 MAD
EXPERIMENTALNGM282 Dose 4 vs Placebo
Cohort 11 MAD
EXPERIMENTALNGM282 Dose 5 vs Placebo
Cohort 12 MAD
EXPERIMENTALNGM282 Dose 6 vs Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Males or females, between 18 and 65 years of age, inclusive
- BMI range is 20-35 kg/m2, inclusive for the SAD Module, and 25-35 kg/m2, inclusive for the MAD Module at Screening;
- In good health, determined by no clinically significant findings from medical history, physical exam, 12 lead ECG, clinical laboratory findings, and vital signs at Screening and Day -1
You may not qualify if:
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder (as determined by the PI)
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NGM Clinical Study Site
Perth, Western Australia, 6009, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alex M DePaoli, MD
NGM Biopharmaceuticals, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2013
First Posted
January 28, 2013
Study Start
January 1, 2013
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
December 31, 2013
Record last verified: 2013-12