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A Phase 1, Double-blind, Randomized, Placebo-controlled, Single- and Multiple-dose Escalating Study

NCT05021666 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2022-09-28

No results posted yet for this study

Summary

This will be a randomized, double-blind, placebo-controlled, single- and multiple SC dose escalating study conducted in 2 parts.

Conditions

  • Healthy Subjects

Interventions

DRUG

Placebo

matching placebo

DRUG

PB 718

dose in the next group will be determined following a review of data from the previous group

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • PegBio Co., Ltd.

    lead OTHER

Principal Investigators

  • Hugh Coleman, MD · Daytona Beach CRU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2022-05-18
Completion
2022-08-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05021666 on ClinicalTrials.gov