臨床研究等提出・公開システム

A phase I, randomized, double-blind, placebo-controlled, inter-individual, ascending dose, multi-site study to assess the safety, tolerability, and pharmacokinetics of AMY109 after a single subcutaneous administration in healthy volunteers and after multiple subcutaneous administrations in patients with endometriosis

A phase I study to assess the safety, tolerability, and pharmacokinetics of AMY109

102

A total of 60 healthy adult males and 16 healthy adult females, and 26 patients with endometriosis were enrolled.

In AMY001JG study, a total of 76 subjects in 9 treatment groups (60 healthy adult males and 16 healthy adult females, and 8 or 10 patients in each group) enrolled to receive a single subcutaneous dose of AMY109 or placebo, and a total of 26 patients with endometriosis in 3 treatment groups (8 or 10 patients in each group) were enrolled to receive AMY109 or placebo subcutaneously 6 times (once every 4 weeks).

Among the healthy adults and patients with endometriosis who received AMY109, the incidences of adverse events were 39.7% (23/58 subjects) and 68.4% (13/19 patients), respectively. The incidence of SAEs in healthy adults and patients who received AMY109 were 1.7% (1/58 subjects) and 10.2 % (2/19 patients), respectively. These SAEs were judged NOT related with AMY109. There was no obvious relationship to dose regarding adverse events including laboratory parameters, ECGs, or vital signs.

AMY109 was generally safe and well-tolerated at doses when administered as single doses to healthy subjects, and between when administered as multiple doses to patients with endometriosis.

AMY109 showed linear pharmacokinetics in healthy subjects and patients with endometriosis. There was no apparent difference of pharmacokinetic parameters between gender, race, or between healthy subjects and patients. There were no apparent dose-related trends with the presence or absence of anti-AMY109 antibodies in healthy subjects (6 [10.3%] of 58 subjects who received AMY109) and patients with endometriosis (5 [26.3%] of 19 patients who received AMY109). No decrease in blood concentration of AMY109 was observed or no anti-AMY109 antibodies suggesting an association with adverse events were reported, so no effect due to immunogenicity has been confirmed.

It was suggested that AMY109 has acceptable safety profile in single dose subcutaneous administration for healthy subjects, and multiple dose subcutaneous administration for patients with endometriosis.

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

clinical-trials@chugai-pharm.co.jp

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

completed

Feb. 26, 2018

Interventional

A single and multiple SC administrations, randomized, double-blind, placebo-controlled, inter-individual, ascending dose, multi-site study

treatment purpose

1

[Healthy male volunteers]
- Aged => 20 and < 55 years

[Healthy female volunteers]
- Non-child bearing potential or pre-menopausal aged => 20 and < 65 years

[Patients with endometriosis]
- Aged => 20 and < 50 years
- Patient has a moderate to severe pain for endometriosis for the screening period

- Any clinically significant abnormalities at the screening tests
- History of hypersensitivity associated with antibody preparations and additive or excipients of AMY109

Both

Healthy volunteers and patients with endometriosis

investigational material(s)
Generic name etc : AMY109
INN of investigational material : -
Therapeutic category code : 639 Other biological preparations
Dosage and Administration for Investigational material : A single and multiple SC administrations of AMY109 (multiple dose levels)

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : A single and multiple SC administrations of the placebo

safety
Observation / inspection

pharmacokinetics
Observation / inspection

Jan. 22, 2018