A phase 1, randomised, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics in healthy adult subjects after subcutaneous injection of TISA-818-Inj-5mg/mL.

Start 9 Jan 2024 · End 16 Oct 2024 · Status Ended · 1 EU/EEA countries · 2 sites · Protocol TISA-818-22101

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 48

Countries 1

Sites 2

Idiopathic pulmonary fibrosis

Key facts

Sponsor: Enlitisa (Shanghai) Pharmaceutical Co. Ltd.
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration: 9 Jan 2024 → 16 Oct 2024
Decision date (initial): 2023-11-27
Transition trial: No
Low-intervention: No
Rare-disease indication: Yes
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Idiopathic pulmonary fibrosis

Version	Level	Code	Term	System organ class
21.1	PT	10021240	Idiopathic pulmonary fibrosis	100000004855

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Enlitisa (Shanghai) Pharmaceutical Co. Ltd.

Sponsor organisation: Enlitisa (Shanghai) Pharmaceutical Co. Ltd.
Address: Room 201 202 203 Building A, Block1 No 800 Qingdai Road Block1 No 800 Qingdai Road
City: Shanghai
Postcode: 201318
Country: China

Scientific contact point

Organisation: Enlitisa (Shanghai) Pharmaceutical Co. Ltd.
Contact name: Gu Ming

Public contact point

Organisation: Enlitisa (Shanghai) Pharmaceutical Co. Ltd.
Contact name: Gu Ming

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Sweden	Ended	48	2
Rest of world	—	0	—

Investigational sites

Sweden

2 sites · Ended

CTC Clinical Trial Consultants AB

CTC, Ingang 85 Vaning 2, 751 85, Uppsala