NCT03918967 is a Phase 1 clinical trial of CT-G11 in Healthy, sponsored by Celltrion.

Who is sponsoring NCT03918967?

NCT03918967 is sponsored by Celltrion.

What drugs are being tested in NCT03918967?

Interventions in NCT03918967: CT-G11, CT-G20, CT-G11 Placebo, CT-G20 Placebo.

Is NCT03918967 still recruiting?

NCT03918967 is currently completed. Last updated 9 June 2020.

Last reviewed 2020-06-09 · How we verify

NCT03918967

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants

Completed Phase 1 Last updated 9 June 2020

What this trial tests

Phase 1 trial testing CT-G11 in Healthy in 72 participants. Completed in 6 June 2020.

Timeline

8 April 2019

Primary endpoint
6 June 2020

6 June 2020

Quick facts

Lead sponsor	Celltrion
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	72
Start date	8 April 2019
Primary completion	6 June 2020
Estimated completion	6 June 2020
Sites	1 location across South Korea

Drugs / interventions tested

CT-G11 — full drug profile →
CT-G20 — full drug profile →
CT-G11 Placebo
CT-G20 Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Celltrion — full company profile →

Who can join

Adults 19 to 55, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants. It will be conducted in three parts, as described below: * Part I will be a randomized, double-blind, placebo-controlled, sequential, single ascending dose study. * Part II will be a randomized, double-blind, placebo-controlled, sequential, multiple ascending dose study. * Part III will be a randomized, open-label, balanced, two-period, two-sequence crossover, food effect study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Celltrion trials

Trials by the same sponsor.

NCT07533539 — Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration · Phase 1 · recruiting
NCT07200986 — Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects · Phase 1 · active not recruiting
NCT07128654 — A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers · Phase 1 · completed
NCT07158346 — Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration · Phase 1 · completed
NCT06952478 — A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03918967 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celltrion
Last refreshed: 9 June 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03918967.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing