NCT01636141 is a Phase 1 clinical trial of OLT1177 Gel in Healthy Volunteers, sponsored by Olatec Therapeutics LLC.

Who is sponsoring NCT01636141?

NCT01636141 is sponsored by Olatec Therapeutics LLC.

What drugs are being tested in NCT01636141?

Interventions in NCT01636141: OLT1177 Gel, Placebo gel.

What condition does NCT01636141 study?

NCT01636141 studies Healthy Volunteers.

Is NCT01636141 still recruiting?

NCT01636141 is currently completed. Last updated 5 September 2012.

Last reviewed 2012-09-05 · How we verify

NCT01636141

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

A Phase 1, Randomized, Dose Escalation, Single Center, Safety Study of Single and Multi-Dose, Topically Applied OLT1177 Gel in Healthy Subjects

Completed Phase 1 Last updated 5 September 2012

What this trial tests

Phase 1 trial testing OLT1177 Gel in Healthy Volunteers in 36 participants. Completed in 1 August 2012.

Timeline

1 June 2012

Primary endpoint
1 August 2012

1 August 2012

Quick facts

Lead sponsor	Olatec Therapeutics LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	treatment
Enrollment	36
Start date	1 June 2012
Primary completion	1 August 2012
Estimated completion	1 August 2012
Sites	1 location across United States

Drugs / interventions tested

OLT1177 Gel — full drug profile →
Placebo gel

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Olatec Therapeutics LLC — full company profile →

Who can join

Adults 18 to 60, any sex, with Healthy Volunteers. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Recording of adverse events
Time frame: Part A - during the 7 days following the application of the study drug and Part B during the 14 day following each application of the study drug
Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event. Local skin irritation will be assessed at each visit based on individual signs and symptoms of skin tolerability for erythema, pruritus, scaling/dryness, edema and stinging/burning.

Sponsor's own description

The purpose of this study is to determine if OLT1177 Gel is safe and can be tolerated when given as a single dose and multidose to a defined area of one knee of healthy subjects.

Publications & conference data

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

The role of inflammasomes in human diseases and their potential as therapeutic targets.
Yao J, Sterling K, Wang Z, Zhang Y, et al · · 2024 · cited 135× · PMID 38177104 · DOI 10.1038/s41392-023-01687-y
The 'speck'-tacular oversight of the NLRP3-pyroptosis pathway on gastrointestinal inflammatory diseases and tumorigenesis.
Arrè V, Scialpi R, Centonze M, Giannelli G, et al · · 2023 · cited 16× · PMID 37891577 · DOI 10.1186/s12929-023-00983-7
The NLRP3 Inflammasome: Mechanisms of Activation, Regulation, and Therapeutic Opportunities.
Zou C, Jiang S, Li H, Zhao K, et al · · 2026 · PMID 41799937 · DOI 10.1002/mco2.70660
Nanotechnology-based targeted regulation of NLRP3 Inflammasome: therapeutic strategies and clinical application prospects in inflammatory diseases.
Zhao X, Xu Z, Wang D, Li T, et al · · 2025 · PMID 41332414 · DOI 10.1080/10717544.2025.2580730

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 Olatec Therapeutics LLC trials

Trials by the same sponsor.

NCT05658575 — Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare · Phase 2, PHASE3 · recruiting
NCT04540120 — Safety and Efficacy of Dapansutrile for Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release S · Phase 2 · terminated
NCT03534297 — Study of Dapansutrile Capsules in Heart Failure · Phase 1 · completed
NCT03595371 — Pilot Study of Dapansutrile Capsules in Schnitzler's Syndrome · Phase 2 · terminated

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 NCT01636141 (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 Olatec Therapeutics LLC
Last refreshed: 5 September 2012

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/NCT01636141.

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