NCT03100630

Brief Summary

Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected into the arm, thigh, or the stomach. Collect data on safety of RO7239361.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2017

Typical duration for phase_1 healthy

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

March 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 9, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2017

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

March 29, 2017

Last Update Submit

August 5, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Maximum observed serum concentration (Cmax)

    Up to 92 days

  • AUC from time zero to time of last quantifiable concentration [AUC(0-T)]

    Up to 92 days

  • AUC from time zero extrapolated to infinite time [AUC(INF)]

    Up to 92 days

Secondary Outcomes (5)

  • Incidence of Adverse Events ( AEs)

    Up to 92 days

  • Incidence of Serious Adverse Events (SAEs)

    Up to 92 days

  • Change from baseline in electrocardiogram findings

    Up to 92 days

  • Change from baseline in physical examination findings

    Up to 92 days

  • Change from baseline in clinical laboratory test findings

    Up to 92 days

Study Arms (3)

Treatment A: RO7239361

ACTIVE COMPARATOR

RO7239361 subcutaneous injections on specified days; abdomen

Drug: RO7239361

Treatment B: RO7239361

ACTIVE COMPARATOR

RO7239361 subcutaneous injections on specified days; arm

Drug: RO7239361

Treatment C: RO7239361

ACTIVE COMPARATOR

RO7239361 subcutaneous injections on specified days; thigh

Drug: RO7239361

Interventions

RO7239361DRUG

Specified dose on specified days

Treatment A: RO7239361Treatment B: RO7239361Treatment C: RO7239361

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy participant as determined by no significant deviations in normal medical and surgical history and assessments
  • Body Mass Index 18 kg/m2 to 32 kg/m2
  • females must be of non-childbearing potential

You may not qualify if:

  • tattoos or other skin findings on any of the potential injection sites
  • history of chronic muscle pain within 30 days prior to study treatment
  • prior history of IgG1 therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WCCT Global, Inc.

Cypress, California, 90630, United States

Location

Related Links

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 4, 2017

Study Start

May 9, 2017

Primary Completion

October 17, 2017

Study Completion

October 17, 2017

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

US(1)