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A Study of RO7830698 in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease

ConditionsChronic Obstructive Pulmonary Disease (COPD)Healthy Participants
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHoffmann-La Roche

About this trial

This study will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of single and multiple doses of RO7830698 in healthy participants and participants with chronic obstructive pulmonary disease (COPD).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body mass index (BMI) between 18 and 32 kilograms per meter square (kg/m2)

Agreement to adhere to the contraception requirements

Absence of evidence of any active or chronic disease

Confirmed diagnosis of COPD for > 6 months, as defined by the Global Initiative for Chronic obstructive Lung Disease (GOLD) guidelines

Disqualifiers

Pregnant or breastfeeding, or planning to become pregnant during the study or within the timeframe in which contraception is required

Current or chronic history of clinically significant liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert syndrome or asymptomatic gallstones) or cirrhosis

Known history of allergy to drugs or other substances, or clinically significant, acute, and/or uncontrolled allergic disease

Known or suspected history of immunosuppression

Trial design

Design model

Parallel

Treatments tested in this trial

  • RO7830698

    Drug

    Participants will receive RO7830698 as per the schedule described in the protocol.

  • Placebo

    Drug

    Participants will receive placebo as per the schedule described in the protocol.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Part 1: Single Ascending Dose (SAD)Experimental treatment 2 interventions
Group B: Part 2: Multiple Ascending Dose (MAD)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part 1: Incidence and Severity of Adverse Events (AEs)

Time frame
Up to approximately 50 weeks
2

Part 2: Incidence and Severity of AEs

Time frame
Up to approximately 44 weeks
3

Part 1: Incidence of Dose-limiting Adverse Events (DLAEs)

Time frame
Up to approximately 50 weeks
4

Part 2: Incidence of DLAEs

Time frame
Up to approximately 44 weeks

Secondary outcomes

1

Part 1 and Part 2: Plasma Concentration of RO7830698

Time frame
Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks
2

Part 1: Bioavailability (F) of RO7830698

Time frame
Up to approximately 50 weeks
3

Part 1: Area Under the Concentration-Time Curve From Time 0 To Infinity (AUC inf) of RO7830698

Time frame
Up to approximately 50 weeks
4

Part 1 and Part 2: Incidence of Anti-Drug Antibodies (ADAs) to RO7830698

Time frame
Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: