The effect of a single escalating dose of long-acting recombinant human follicle-stimulating hormone Fc fusion protein (KN015) on healthy, pituitary-suppressed women: first-in-human and randomized study on its pharmacokinetics, pharmacodynamics, and tolerability.
Expert Opin Investig Drugs
; 31(11): 1255-1263, 2022 Nov.
Article
em En
| MEDLINE
| ID: mdl-36537742
ABSTRACT
OBJECTIVE:
KN015 is a long-acting, recombinant human follicle-stimulating hormone Fc fusion protein that induces follicle development. This first-in-human study evaluated the effect of KN015 on healthy, pituitary-suppressed women and examined its pharmacokinetics, pharmacodynamics, and tolerability.METHODS:
This phase I study was a double-blind, randomized, and placebo-controlled design with a single ascending dose (20, 40, and 60 µg, respectively).RESULTS:
After subcutaneous administration of a single dose, the maximum serum KN015 concentrations reached 1.57, 2.78, and 3.62 ng/mL, respectively, after baseline adjustment. Over this dose range, the median Tmax occurred at 240-312 h, and the half-life (t½) was 752-1160 h. Dose proportionality was shown across the studied dose range. In most subjects, follicular growth was observed, and the number and diameter of the follicles increased with an increasing dose. In the 40-µg and 60-µg groups, the mean numbers of follicles with a diameter of ≥17 mm were 3 and 4, respectively. There was no significant difference in adverse events between the KN015 and placebo groups. KN015 antibody was not detected in any of the dosage groups.CONCLUSION:
The administration of a single ascending dose of KN015 was tolerated and able to induce follicular growth. TRIAL REGISTRATION This trial is registered at the Chinese Clinical Trials website (http//www.chinadrugtrials.org.cn/index.html # CTR20160741) and ClinicalTrials.gov (https//clinicaltrials.gov/ # NCT03192527).Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Hormônio Foliculoestimulante Humano
/
Hormônio Foliculoestimulante
Tipo de estudo:
Clinical_trials
Limite:
Female
/
Humans
Idioma:
En
Revista:
Expert Opin Investig Drugs
Assunto da revista:
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
China