NCT05238493 is a Phase 1 clinical trial of VEL-101 in Healthy Volunteers, sponsored by Veloxis Pharmaceuticals.

Who is sponsoring NCT05238493?

NCT05238493 is sponsored by Veloxis Pharmaceuticals.

What drugs are being tested in NCT05238493?

Interventions in NCT05238493: VEL-101, Placebo.

What condition does NCT05238493 study?

NCT05238493 studies Healthy Volunteers.

Is NCT05238493 still recruiting?

NCT05238493 is currently completed. Last updated 27 June 2024.

Last reviewed 2024-06-27 · How we verify

NCT05238493

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

A Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101

Completed Phase 1 Last updated 27 June 2024

What this trial tests

Phase 1 trial testing VEL-101 in Healthy Volunteers in 60 participants. Completed in 3 January 2023.

Timeline

26 April 2022

Primary endpoint
3 January 2023

3 January 2023

Quick facts

Lead sponsor	Veloxis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	other
Enrollment	60
Start date	26 April 2022
Primary completion	3 January 2023
Estimated completion	3 January 2023
Sites	1 location across United States

Drugs / interventions tested

VEL-101 — full drug profile →
Placebo

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Veloxis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is primarily designed to assess the safety and tolerability of single doses of VEL-101 when administered subcutaneously (via injection into an area under the skin) or intravenously (via infusion into a vein). As each new group of participants is enrolled into the study, the dose administered to that group may be higher than a previous dose shown to be safe in other participants. The study is also designed to determine blood levels of VEL-101 and some substances produced by the immune system following VEL-101 administration. This information can provide insight into how quickly VEL-101 is eliminated from the body and some if its effects on the body.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

PEGylated therapeutics in the clinic.
Gao Y, Joshi M, Zhao Z, Mitragotri S. · · 2024 · cited 133× · PMID 38193121 · DOI 10.1002/btm2.10600
Costimulation blockade and Tregs in solid organ transplantation.
Muckenhuber M, Wekerle T, Schwarz C. · · 2022 · cited 8× · PMID 36119115 · DOI 10.3389/fimmu.2022.969633
T-B Collaboration in Autoimmunity, Infection, and Transplantation.
DiToro D, Murakami N, Pillai S. · · 2024 · cited 3× · PMID 37314442 · DOI 10.1097/tp.0000000000004671
Safety, Pharmacokinetics, and Pharmacodynamics of Fixed-dose, Subcutaneous, and Intravenous Administration of VEL-101, an Anti-CD28 PEGylated Monoclonal Antibody Fragment, in Healthy Participants: A Randomized, Double-blind, Placebo-controlled, Dose Escalation, Phase 1 Study.
Tremblay S, Abaigar A, Allton P, Sardinha D, et al · · 2026 · PMID 42083151 · DOI 10.1097/tp.0000000000005701

Verify or expand the search:

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Veloxis Pharmaceuticals trials

Trials by the same sponsor.

NCT05251727 — Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients · Phase 1 · terminated
NCT02411604 — Expanded Access Study for Renal Transplant Patients With Envarsus XR ™ · approved for marketing

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 NCT05238493 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Veloxis Pharmaceuticals
Last refreshed: 27 June 2024

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/NCT05238493.

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