Phase 1 SAD and MAD Study of NGM282 in Healthy Adult Participants

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

NGM Biopharmaceuticals, Inc

ClinicalTrials.gov Identifier:

NCT01776528

First received: January 18, 2013

Last updated: December 30, 2013

Last verified: December 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus	Biological: NGM282 Biological: Placebo	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
Official 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

Further study details as provided by NGM Biopharmaceuticals, Inc:

Primary Outcome Measures:

Safety and tolerability [ Time Frame: 7 days and 14 days ]
To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: 7 days and 14 days ]
To evaluate the pharmacokinetics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.
Pharmacodynamics [ Time Frame: 7 days and 14 days ]
To evaluate the pharmacodynamics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.


Enrollment:	119
Study Start Date:	January 2013
Study Completion Date:	July 2013
Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort 1 SAD NGM282 Dose 1 vs Placebo	Biological: NGM282 Biological: Placebo
Experimental: Cohort 2 SAD NGM282 Dose 2 vs Placebo	Biological: NGM282 Biological: Placebo
Experimental: Cohort 3 SAD NGM282 Dose 3 vs Placebo	Biological: NGM282 Biological: Placebo
Experimental: Cohort 4 SAD NGM282 Dose 4 vs Placebo	Biological: NGM282 Biological: Placebo
Experimental: Cohort 5 SAD NGM282 Dose 5 vs Placebo	Biological: NGM282 Biological: Placebo
Experimental: Cohort 6 SAD NGM282 Dose 6 vs Placebo	Biological: NGM282 Biological: Placebo
Experimental: Cohort 7 MAD NGM282 Dose 1 vs Placebo	Biological: NGM282 Biological: Placebo
Experimental: Cohort 8 MAD NGM282 Dose 2 vs Placebo	Biological: NGM282 Biological: Placebo
Experimental: Cohort 9 MAD NGM282 Dose 3 vs Placebo	Biological: NGM282 Biological: Placebo
Experimental: Cohort 10 MAD NGM282 Dose 4 vs Placebo	Biological: NGM282 Biological: Placebo
Experimental: Cohort 11 MAD NGM282 Dose 5 vs Placebo	Biological: NGM282 Biological: Placebo
Experimental: Cohort 12 MAD NGM282 Dose 6 vs Placebo	Biological: NGM282 Biological: Placebo

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776528

Locations


Australia, Western Australia
NGM Clinical Study Site
Perth, Western Australia, Australia, 6009

Sponsors and Collaborators

NGM Biopharmaceuticals, Inc

Investigators


Study Director:	Alex M DePaoli, MD	NGM Biopharmaceuticals, Inc

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site


Responsible Party:	NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT01776528 History of Changes
Other Study ID Numbers:	12-0101
Study First Received:	January 18, 2013
Last Updated:	December 30, 2013

Additional relevant MeSH terms:


Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

ClinicalTrials.gov processed this record on August 17, 2017

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