NCT03392116

Brief Summary

The purpose is to evaluate the safety, tolerability, and PK of NGM120 in healthy adult subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

January 29, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

12 months

First QC Date

December 8, 2017

Last Update Submit

August 19, 2019

Conditions

Cachexia

Outcome Measures

Primary Outcomes (2)

  • Part A Arm-Single Dose: Treatment Emergent Adverse events

    Percentage of total subjects with Treatment Emergent Adverse event

    28 days

  • Part B Arm-Multiple Dose: Treatment Emergent Adverse events

    Percentage of total subjects with Treatment Emergent Adverse event

    84 days

Study Arms (4)

Part A: NGM120

EXPERIMENTAL

Single Dose

Biological: NGM120

Part A: Placebo

PLACEBO COMPARATOR

Single Dose

Other: Placebo

Part B: NGM120

EXPERIMENTAL

Multiple Dose

Biological: NGM120

Part B: Placebo

PLACEBO COMPARATOR

Multiple Dose

Other: Placebo

Interventions

NGM120BIOLOGICAL

Subcutaneous Injection

Part A: NGM120Part B: NGM120
PlaceboOTHER

Subcutaneous Injection

Part A: PlaceboPart B: Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal ECG findings

You may not qualify if:

  • Significant history or clinical manifestation of any allergic, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network Limited

Melbourne, Australia

Location

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

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

December 8, 2017

First Posted

January 5, 2018

Study Start

January 29, 2018

Primary Completion

January 14, 2019

Study Completion

March 11, 2019

Last Updated

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)