Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03392116




Registration number
NCT03392116
Ethics application status
Date submitted
8/12/2017
Date registered
5/01/2018
Date last updated
20/08/2019

Titles & IDs
Public title
Single and Multiple Ascending Dose Study of NGM120 in Healthy Adult Subjects
Scientific title
A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM120 in Healthy Adult Subjects
Secondary ID [1] 0 0
17-0401
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cachexia 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - NGM120
Other interventions - Placebo

Experimental: Part A: NGM120 - Single Dose

Placebo comparator: Part A: Placebo - Single Dose

Experimental: Part B: NGM120 - Multiple Dose

Placebo comparator: Part B: Placebo - Multiple Dose


Treatment: Other: NGM120
Subcutaneous Injection

Other interventions: Placebo
Subcutaneous Injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A Arm-Single Dose: Treatment Emergent Adverse events
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Part B Arm-Multiple Dose: Treatment Emergent Adverse events
Timepoint [2] 0 0
84 days

Eligibility
Key inclusion criteria
* Normal ECG findings
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 allergic, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorder

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
29/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/03/2019
Sample size
Target
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network Limited - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose is to evaluate the safety, tolerability, and PK of NGM120 in healthy adult subjects
Trial website
https://clinicaltrials.gov/study/NCT03392116
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT03392116