A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorHoffmann-La Roche

About this trial

The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants must be males or females who are overtly healthy as determined by medical evaluation

Participants must have body weight (BW) ≥ 40 kilograms (kg) (not applicable to Cohort A9) and body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m²) (inclusive)

Must be of ethnic Chinese, Korean, or Japanese origin

Must have a BW >35 kg and BMI within the range 18-32 kg/m2 (inclusive)

Disqualifiers

Pregnancy, breastfeeding, or intention to become pregnant during the study or within 6 months after the final dose of study treatment

History of any clinically significant autoimmune, gastrointestinal, renal, hepatic, pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer or cirrhosis

Latent tuberculosis (TB) or potentially active TB

Any major illness within 1 month before the screening examination or any febrile illness within 1 week prior to the screening visit and up to first dose administration

Trial design

Design model

Parallel

Treatments tested in this trial

  • RO7806881

    Drug

    RO7806881 will be administered as per the schedule specified in the protocol.

  • Placebo

    Drug

    Placebo will be administered as per the schedule specified in the protocol.

Treatment groups

128 Participants
are divided into 4 treatment groups
Group A: RO7806881: Single Ascending Dose (SAD)Experimental treatment 1 intervention
Group B: Placebo: SADPlacebo comparator 1 intervention
Group C: RO7806881: Multiple Ascending Doses (MAD)Experimental treatment 1 intervention
Group D: Placebo: MADPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

SAD Part: Number of Participants With Adverse Events (AEs)

Time frame
Up to Day 127
2

MAD Part: Number of Participants With AEs

Time frame
Up to Day 162
3

SAD Part: Number of Participants With Dose-limiting Adverse Events (DLAEs)

Time frame
Up to Day 127
4

MAD Part: Number of Participants With DLAEs

Time frame
Up to Day 162

Secondary outcomes

1

SAD and MAD Parts: Serum Concentration of RO7806881

Time frame
SAD: Up to Day 127; MAD: Up to Day 162
2

SAD and MAD Parts: Maximum Concentration (Cmax) of RO7806881

Time frame
SAD: Up to Day 127; MAD: Up to Day 162
3

SAD and MAD Parts: Minimum Concentration (Cmin) of RO7806881

Time frame
SAD: Up to Day 127; MAD: Up to Day 162
4

SAD and MAD Parts: Area Under the Curve (AUC) From the Last Time of Dosing to the Last Measurable Concentration (AUClast) of RO7806881

Time frame
SAD: Up to Day 127; MAD: Up to Day 162

Other outcomes

Sponsors and contacts

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