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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01776528




Registration number
NCT01776528
Ethics application status
Date submitted
18/01/2013
Date registered
28/01/2013
Date last updated
31/12/2013

Titles & IDs
Public title
Phase 1 SAD and MAD Study of NGM282 in Healthy Adult Participants
Scientific title
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
Secondary ID [1] 0 0
12-0101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Cohort 1 SAD - NGM282 Dose 1 vs Placebo

Experimental: Cohort 2 SAD - NGM282 Dose 2 vs Placebo

Experimental: Cohort 3 SAD - NGM282 Dose 3 vs Placebo

Experimental: Cohort 4 SAD - NGM282 Dose 4 vs Placebo

Experimental: Cohort 5 SAD - NGM282 Dose 5 vs Placebo

Experimental: Cohort 6 SAD - NGM282 Dose 6 vs Placebo

Experimental: Cohort 7 MAD - NGM282 Dose 1 vs Placebo

Experimental: Cohort 8 MAD - NGM282 Dose 2 vs Placebo

Experimental: Cohort 9 MAD - NGM282 Dose 3 vs Placebo

Experimental: Cohort 10 MAD - NGM282 Dose 4 vs Placebo

Experimental: Cohort 11 MAD - NGM282 Dose 5 vs Placebo

Experimental: Cohort 12 MAD - NGM282 Dose 6 vs Placebo
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability
Timepoint [1] 0 0
7 days and 14 days
Secondary outcome [1] 0 0
Pharmacokinetics
Timepoint [1] 0 0
7 days and 14 days
Secondary outcome [2] 0 0
Pharmacodynamics
Timepoint [2] 0 0
7 days and 14 days

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
NGM Clinical Study Site - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
NGM Biopharmaceuticals, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01776528
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alex M DePaoli, MD
Address 0 0
NGM Biopharmaceuticals, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01776528