NCT06205524 is a Phase 1 clinical trial of TI-0010 in COVID-19, sponsored by National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College.

What drugs are being tested in NCT06205524?

Interventions in NCT06205524: TI-0010, Placebo.

What condition does NCT06205524 study?

NCT06205524 studies COVID-19, COVID-19 Immunisation.

Is NCT06205524 still recruiting?

NCT06205524 is currently status unknown. Last updated 18 January 2024.

Last reviewed 2024-01-18 · How we verify

NCT06205524

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

A Study to Evealuate Safety and Immunogenicity of TI-0010 SARS-CoV-2 Vaccine in Healthy Adults

Status unknown Phase 1 Last updated 18 January 2024

What this trial tests

Phase 1 trial testing TI-0010 in COVID-19 in 100 participants. Status unknown.

Timeline

10 July 2023

Primary endpoint
1 December 2024

1 February 2025

Quick facts

Lead sponsor	National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	100
Start date	10 July 2023
Primary completion	1 December 2024
Estimated completion	1 February 2025
Sites	1 location across China

Drugs / interventions tested

TI-0010 — full drug profile →
Placebo

Conditions studied

COVID-19 — all drugs for COVID-19 →
COVID-19 Immunisation — all drugs for COVID-19 Immunisation →

Sponsor

National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College

Who can join

Adults 18 to 59, any sex, with COVID-19 or COVID-19 Immunisation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a randomized, double-blind, placebo controlled clinical exploratory study to evaluate the safety, tolerability and immunogenicity of TI-0010 vaccine in healthy adults aged 18-59. TI-0010 was manufactured by Therorna Inc. TI-0010 is a novel lipid nanoparticles (LNP) -encapsulated circRNA-based vaccine targeting RBD of SARS-CoV-2. Up to one hundred subjects will be enrolled into one of 4 cohorts. Low-dose(Dose Level 1) is for Cohort 1 and Cohort 2 , and the high dose (Dose Level 2) for Cohort 3 and Cohort 4. Cohort 1 and Cohort 3 receive 2 doses (with a 28 day interval) via intramuscular injection respectively, and Cohort 2 and Cohort 4 receive 1 dose via intramuscular injection respectively. Participants are randomized to receive TI-0010 or placebo in a 4:1 ratio.

Publications & conference data

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

Navigating the intricate in-vivo journey of lipid nanoparticles tailored for the targeted delivery of RNA therapeutics: a quality-by-design approach.
Haghighi E, Abolmaali SS, Dehshahri A, Mousavi Shaegh SA, et al · · 2024 · cited 28× · PMID 39543630 · DOI 10.1186/s12951-024-02972-w
Harnessing the Loop: The Perspective of Circular RNA in Modern Therapeutics.
Zhao YY, Zhu FM, Zhang YJ, Wei HY. · · 2025 · cited 2× · PMID 40872908 · DOI 10.3390/vaccines13080821
Circular RNA as a New Vaccine Platform: Considerations, Challenges, and Perspectives.
Lee KH, Lee J, Lee SW. · · 2026 · PMID 41893758 · DOI 10.3390/vaccines14030221

Verify or expand the search:

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not 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 NCT06205524 (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 National Drug Clinical Trial Institute of the Second Affiliated Hospital of Bengbu Medical College
Last refreshed: 18 January 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/NCT06205524.

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