NCT01284036 (FIH) is a Phase 1 clinical trial of PF-05230905 in Healthy, sponsored by Ablynx, a Sanofi company.

Who is sponsoring NCT01284036?

NCT01284036 is sponsored by Ablynx, a Sanofi company.

What drugs are being tested in NCT01284036?

Interventions in NCT01284036: PF-05230905.

Is NCT01284036 still recruiting?

NCT01284036 is currently completed. Last updated 30 January 2013.

Last reviewed 2013-01-30 · How we verify

NCT01284036: FIH

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

Ascending Single Dose Study Of The Safety, Tolerability, And Pharmacokinetics Of PF-05230905 Administered Subcutaneously Or Intravenously To Healthy Subjects

Completed Phase 1 Last updated 30 January 2013

What this trial tests

Phase 1 trial testing PF-05230905 in Healthy in 63 participants. Completed in 1 November 2011.

Timeline

1 October 2010

Primary endpoint
1 November 2011

1 November 2011

Quick facts

Lead sponsor	Ablynx, a Sanofi company
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	triple
Enrollment	63
Start date	1 October 2010
Primary completion	1 November 2011
Estimated completion	1 November 2011
Sites	1 location across United States

Drugs / interventions tested

PF-05230905 — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Ablynx, a Sanofi company — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Healthy volunteers can join.

What's being measured

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

Safety endpoints will be evaluated by comparing reported adverse events in subjects receiving PF-05230905 versus subjects receiving placebo.
Time frame: day 168
Incidence and severity of clinical laboratories including absolute hepatic transaminases and bilirubin levels will be evaluated.
Time frame: day 168
Mean change from baseline in vital signs measurements. Mean change from baseline in 12 lead echocardiogram (ECG) will be compared to ensure safety of the subjects.
Time frame: day 168

Sponsor's own description

The purpose of this study is to find the safety and side effects of investigational drug in healthy volunteers. See how quickly investigational drug enters the bloodstream, is distributed in the body, broken down and removed in healthy male and female volunteers. See if your body makes antibodies to this investigational drug (how your immune system responds).

Publications & conference data

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

The Therapeutic Potential of Nanobodies.
Jovčevska I, Muyldermans S. · · 2020 · cited 535× · PMID 31686399 · DOI 10.1007/s40259-019-00392-z
A comprehensive comparison between camelid nanobodies and single chain variable fragments.
Asaadi Y, Jouneghani FF, Janani S, Rahbarizadeh F. · · 2021 · cited 123× · PMID 34863296 · DOI 10.1186/s40364-021-00332-6
Nanobodies: Robust miniprotein binders in biomedicine.
Yong Joon Kim J, Sang Z, Xiang Y, Shen Z, et al · · 2023 · cited 46× · PMID 36754285 · DOI 10.1016/j.addr.2023.114726
Live long and active: Polypeptide-mediated assembly of antibody variable fragments.
Lee C, Choi M, MacKay JA. · · 2020 · cited 8× · PMID 33129938 · DOI 10.1016/j.addr.2020.10.017

Verify or expand the search:

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Other Ablynx, a Sanofi company trials

Trials by the same sponsor.

NCT03418571 — Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infecti · Phase 2 · terminated
NCT03172208 — Caplacizumab Single and Multiple Dose Study in Healthy Japanese and White Subjects. · Phase 1 · completed
NCT02979431 — Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection · Phase 2 · completed
NCT02101073 — ALX-0061 Phase I Bioavailability Study in Healthy Volunteers · Phase 1 · completed

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 NCT01284036 (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 Ablynx, a Sanofi company
Last refreshed: 30 January 2013

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/NCT01284036.

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