Last reviewed · How we verify
NCT00547014
Oral Administration Of CPG 52364 In Healthy Subjects: A Phase 1, Within-Cohort Randomized, Double-Blinded, Placebo-Controlled, Ascending Single-Dose, Single-Center Study
Phase 1 trial testing Placebo Comparator: Cohort 1 Placebo in Healthy Volunteers in 61 participants. Completed in 1 April 2008.
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Enrollment | 61 |
| Start date | 1 September 2007 |
| Estimated completion | 1 April 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Placebo Comparator: Cohort 1 Placebo
- 52364 3 mg — full drug profile →
- Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo
- 52364 10 mg — full drug profile →
- 52364 30 mg — full drug profile →
- 52364 100 mg — full drug profile →
- 52364 1 mg — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Pfizer — full company profile →
Who can join
Adults 18 to 65, 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.
-
Clinical Assessment of Adverse Events
Time frame: 28 days/subject
Sponsor's own description
Determine the safety and tolerability of the study drug, CPG 52364, when given as liquid or capsule. Another purpose is to determine how the drug enters and leaves the blood stream and body tissues over time.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Inhibition of Toll-Like Receptor Signaling as a Promising Therapy for Inflammatory Diseases: A Journey from Molecular to Nano Therapeutics.
Gao W, Xiong Y, Li Q, Yang H. · · 2017 · cited 266× · PMID 28769820 · DOI 10.3389/fphys.2017.00508 -
Recent clinical trends in Toll-like receptor targeting therapeutics.
Anwar MA, Shah M, Kim J, Choi S. · · 2019 · cited 209× · PMID 30450666 · DOI 10.1002/med.21553 -
Small Molecule NF-κB Pathway Inhibitors in Clinic.
Ramadass V, Vaiyapuri T, Tergaonkar V. · · 2020 · cited 154× · PMID 32708302 · DOI 10.3390/ijms21145164 -
Plasmacytoid dendritic cell biology and its role in immune-mediated diseases.
Ye Y, Gaugler B, Mohty M, Malard F. · · 2020 · cited 107× · PMID 32489664 · DOI 10.1002/cti2.1139 -
Agonist and antagonist ligands of toll-like receptors 7 and 8: Ingenious tools for therapeutic purposes.
Patinote C, Karroum NB, Moarbess G, Cirnat N, et al · · 2020 · cited 87× · PMID 32203790 · DOI 10.1016/j.ejmech.2020.112238 -
Targeted therapeutics in SLE: emerging strategies to modulate the interferon pathway.
Oon S, Wilson NJ, Wicks I. · · 2016 · cited 58× · PMID 27350879 · DOI 10.1038/cti.2016.26 -
Therapeutic applications of nucleic acids and their analogues in Toll-like receptor signaling.
Gosu V, Basith S, Kwon OP, Choi S. · · 2012 · cited 50× · PMID 23151919 · DOI 10.3390/molecules171113503 -
The NF-κB Pharmacopeia: Novel Strategies to Subdue an Intractable Target.
Verzella D, Cornice J, Arboretto P, Vecchiotti D, et al · · 2022 · cited 23× · PMID 36140335 · DOI 10.3390/biomedicines10092233
Verify or expand the search:
- PubMed search for NCT00547014
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 Pfizer trials
Trials by the same sponsor.
- NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
- NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
- NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
- NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
- NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00547014 (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 Pfizer
- Last refreshed: 18 March 2009
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/NCT00547014.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing