Trial reportClinical pharmacology in drug development2026
Randomized Phase 1 Studies Evaluating the Safety, Tolerability, Pharmacokinetics, and Target Occupancy of Zampilimab in Healthy Participants.
Trial report in Clinical pharmacology in drug development, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02879877 (A Subject-blind, Investigator-blind, Randomized, Placebo-controlled, First-in-human Study Evaluating the Safety/Tolerability, Pharmacokinetics, Effect on Transglutaminase 2 Expression, and Occupancy of Single Ascending Intravenous and Subcutaneous Doses of UCB7858 in Healthy Subjects), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Subject-blind, Investigator-blind, Randomized, Placebo-controlled, First-in-human Study Evaluating the Safety/Tolerability, Pharmacokinetics, Effect on Transglutaminase 2 Expression, and Occupancy of Single Ascending Intravenous and Subcutaneous Doses of UCB7858 in Healthy Subjects
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Authors and funding
11 authors.
Funding
Abstract
Zampilimab (UCB7858) is a humanized monoclonal immunoglobulin G4P, transglutaminase 2 (TG2) inhibiting antibody. We investigated safety, tolerability, pharmacokinetics, and target occupancy of zampilimab (intravenous ≤2000 mg; subcutaneous ≤1000 mg) in healthy participants in a randomized, placebo‑controlled, single-ascending-dose Phase 1 study (UP0029; NCT02879877). Of 78 participants (58 zampilimab; 20 placebo), treatment-emergent adverse events (TEAEs) occurred in 42 (72.4%) versus 14 (70%), respectively. One participant (intravenous zampilimab 2000 mg) reported a serious TEAE of moderate infusion-related reaction (a protocol-defined stopping criterion), leading to a temporary study hold. Although the reaction resolved within 3 days, and the participant completed follow up, dose-escalation was suspended, and the study terminated. Zampilimab demonstrated dose-proportional, linear pharmacokinetics (t
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